Vitamin and mineral supplements for human and veterinary use are commonplace. Nutrient intake surveys have shown large segments of the world's population consumes substantially less than the recommended amounts of numerous vitamins and minerals. For example, in the U.S.A. 60% or more of females age 20-29 years consume less than the recommended dietary allowance of vitamins A, E, B-6, folic acid, and the minerals calcium, magnesium, iron, and zinc. It is generally known that some diets, heavy physical exercise and disease conditions may require the intake of considerable quantities of vitamins and minerals apart from those generally available from what is considered a normal diet. Nutritional supplements are primarily important for those who have inadequate diets, however, individuals with a reduced ability to utilize or absorb vitamins and minerals from food, e.g., the elderly, also need nutritional supplementation.
Commercially available vitamin and mineral supplements are convenient and useful in many circumstances where improved nutrient uptake is desirable. However, adhering to a daily routine of nutritional supplementation has had limited success. For example, daily supplementation requires a change in normal habits and practices of the user. Further, some individuals find that supplements provide no immediate physiological signal to help them perceive a benefit or to establish a consistent routine of use. A number of other pharmacologic agents taken for health are typically associated with a noticeable bodily or physiological response. It is believed that the lack of a physiological signal limits the overall acceptability of nutritional supplements which is unfortunate since there is a need for supplementation to augment the daily intake of vitamins and minerals from foods.
A physiological signal that many people are accustomed to is the alertness response received by food-type tonics or bracers, such as caffeine. These materials can be useful for creating a perceived benefit and for establishing more regular use of nutritional supplements. These natural bracers, and in particular, the xanthine alkaloids (methylxanthines) are found in various plants. The methylxanthines are obtained by extraction of plants (e.g. coffee beans, cola nuts, tea plants). Plants containing methylxanthines are known to those skilled in the art. Preferred methylxanthines are 1, 3, 7-trimethylxanthine (caffeine), 1, 3-dimethylxanthine (theophylline) and 3, 7-dimethylxanthine (theobromine). Many people establish a consistent pattern of caffeine use due to its well documented effects as a tonic. One or more caffeine containing food or beverages-cocoa, chocolate, coffee, tea, soft drinks--are consumed daily by most adults and children. Cocoa and chocolate contain only small amounts of caffeine and are not usually consumed for the same reason as coffee, tea, and soft drinks.
Although it is clear that many people consume caffeine and other related tonics, there are well recognized problems with the usual caffeine containing foods. Caffeinenated coffee is consumed by many people in the morning. Coffee is known to stimulate the gastric mucosa and increase stomach acid secretions which contributes to heart burn and irritation of ulcers. Coffee is also bitter tasting, so some people consume caffeine in the form of soft drinks. The high acid content of soft drinks, phosphoric for colas and "pepper" type soft drinks and citric acid for fruit flavored type beverages is well documented to etch or erode the enamel of the tooth surface. In addition, cola and "pepper" type soft drinks contributed greatly to the total phosphorus intake of the diet which imbalances the calcium to phosphorus ratio and can cause a negative effect on bone metabolism. Tea is another widely consumed source of caffeine but it also has some negatives associated with it. Tea contains anti-thiamin factors which stress the thiamin stores in the body and can lead to poor thiamin nutritional status. In addition, teas are often consumed with lemon and/or sugar. The lemon can increase the risk of dental erosion due to etching of the teeth from the high citric acid content and the sugar can provide a source of fermentable carbohydrate to the oral bacteria which increases the risk of caries. Apart from the negative effect of caffeine containing beverages, many people look for alternative ways to provide alertness benefits.
It would be desirable to provide the sought after bracing effects of caffeine or other similar ingredients in a composition which eliminates the negative effects of normal caffeine source carriers and yet provide a convenient and effective composition for promoting good health.
Thus, an object of the current invention is to provide compositions of vitamins and/or minerals and a central nervous system tonic in a convenient dose form. These compositions would provide vitamin and mineral supplements with a noticeable physiologic response and also the desired alertness effects without the negative components associated with typical caffeine containing beverages.
Some people avoid caffeine due to health reasons, i.e. the effect of caffeine on elevating blood pressure. It would be desirable, therefore, to have additional nutritional supplements which provide a physiological signal other than those of methylxanthines. Green tea is believed to have a relaxing benefit owing to the presence of flavanols (i.e., the catechins and epicatechins). Green tea has had several physiologic benefits attributed to it. It is believed to lower blood pressure and have other soothing and healing effects. These benefits have been attributed to flavanols. Black tea contains polymerized flavanols which do not impart the same degree of benefits of catechins and epicatechins.
Compositions comprising vitamins and/or minerals and flavanols would be useful as a convenient dose form for improving the diet while also providing a physiologic response and combined benefits of flavanols with those of vitamins and minerals to yield a more comprehensive product for the promotion of health.
It is further recognized that certain individuals seek the benefits of caffeine or similar ingredients but, closely control the amount of caffeine they ingest due to sensitivity to caffeine or because of caffeines undesirable effects (i.e. the promotion of nervousness). For some people, the negative effects of caffeine may eventually outweigh the positive so that caffeine is avoided altogether. Tea contains caffeine. However, the caffeine in tea does not appear to be as physiologically available due to the presence of flavanols. It is well known that the flavanols, in particular the unoxidized flavanols, present in green tea, help to control the negative effects of caffeine. See, for example, French patent No. 2,586,532 issued to Balansard et al.
Vitamin and mineral supplements having unique compositions containing a bracer, such as caffeine, along with the beneficial effects of flavanols or green tea would be useful for improving nutritional status and providing positive alertness benefits while limiting the negative effects.
Both caffeine and flavanol containing products are primarily consumed in the morning to obtain an alertness effect. Typically vitamins and minerals are also consumed in the morning. It would be more convenient if the nutritional supplements, methylxanthines and flavanols could be administered conjointly in a form which would provide nutritional supplementation and alertness without negative effects. These nutrient supplement compositions would be useful in providing a physiologically positive alertness benefit while providing feedback beneficial in establishing more regular use of a supplement.
The use of methylxanthines and/or flavanols are known in pharmaceutical and therapeutic preparations. The methylxanthines have primarily been used to treat various problems such as asthma, abdominal complications, and migraine headaches. However methylxanthines and in particular, caffeine, is used to counteract the adverse effects (i.e. drowsiness) caused by other ingredients in the pharmaceutical preparation. The flavanols, have been used for centuries to combat numerous diseases and illnesses, both real and imaginary.
While the beneficial effects of methylxanthines and flavanols, in particular caffeine and green tea, are suggested by the literature, the use of these materials in conjunction with vitamin and mineral supplements or the coadministering of the materials with vitamins and minerals in a convenient form is not known.
It would be desirable, therefore, to have vitamin and mineral supplements containing flavanols and methylxanthines or flavanols alone wherein physiological feedback is achieved.
It is an object of this invention to provide nutritional supplements which provide the physiologically positive alertness effects of a bracer along with the beneficial effects of the flavanols or green tea solids.
Another object of this invention is to provide a composition which reduces a multistep morning ritual for many people into a single convenient dose form.
It is further an object of this invention to provide vitamin i and mineral supplements which when taken, help to establish consistent use of the supplements.
These and other objects will become apparent from the description herein.
All percentages are by weight per unit dose unless otherwise indicated.